Trials / Unknown
UnknownNCT02925806
Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products
Drug Utilization Study of Trends in Prescriptions for Class REMS ER/LA Opioids and Comparator Products; Evaluation of Drug Utilization Patterns
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,575,834 (estimated)
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC) · Industry
- Sex
- All
- Age
- 100 Years
- Healthy volunteers
- —
Summary
A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.
Detailed description
A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products. The specific objectives of the Drug Utilization Study are: 1. To estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the REMS 2. To compare average number of prescriptions per 3 month (quarter) period in the 2 years before as compared to the same measure during Implementation and the Active Period 3. To evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty) 4. To compare the trends in prescribing, both number of prescriptions and patients, by prescriber specialty These trends and changes over time will be estimated for the following groups of opioids: * ER/LA opioids included in the class REMS * Comparator products/classes * Immediate release (IR) opioids * Celecoxib * Benzodiazepines 5. To show switches (absolute and rates of switching) from ER/LA opioids to comparator analgesics (IR opioids or celecoxib) with introduction of REMS
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Non-interventional study - retrospective database review |
Timeline
- Primary completion
- 2019-07-01
- First posted
- 2016-10-06
- Last updated
- 2016-10-06
Source: ClinicalTrials.gov record NCT02925806. Inclusion in this directory is not an endorsement.